Combination With DMARDsPhase 3NCT01787149
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis
A Phase 3 study testing DMARDs in people with Combination With DMARDs, run by Mycenax Biotech Inc. at 7 sites in Taiwan.
Trial summary
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with DMARDs versus DMARDs Alone in Patients with Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Combination With DMARDs
- What is being tested?
- DMARDs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 7 sitesTaiwan
- Study dates
- Sep 2013to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥ 20 years old;
- Patient meet ACR criteria for rheumatoid arthritis over 6 month duration;
- Patient with active disease at the time of screening as defined by six or more swollen joints and six or more tender joints;
- Presence of at least one of the following criteria:
- Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h,
- C-Reactive Protein (CRP) ≥ 10 mg/L,
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- RA functional class I, II, or III;
- Patients have been received stable doses of permitted DMARDs (methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, and leflunomide) for at least 8 weeks prior enrollment.
- Patient is willing and able to comply with study procedures and sign informed consent.
Who cannot join
- Active autoimmune disease (other than RA) requiring immunosuppressive therapy;
- In the opinion of the investigator, the patient shows persistent signs of immunosuppression;
- Known hypersensitivity to etanercept or ENIA11 or any of its components;
- Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a soluble TNF receptor (e.g., infliximab);
- Suspected or diagnosed pulmonary tuberculosis, or other chronic or current infectious disease at discretion of investigator;
- Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
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- Patients with any of the following laboratory abnormalities: ALT/AST > 3 times ULN, creatinine > 2 mg/dl, WBC < 3,000/mm3, Hgb < 8.5 g/dL, platelet count < 100,000/mm3;
- Patients have received live attenuated vaccination program within 3 months or BCG vaccine within 12 months prior enrollment;
- Female patient of childbearing potential who:
- is lactating; or
- has positive urine pregnancy test at Visit 1; or
- refuse to adopt reliable method of contraception during the study;
- Diagnosis of primary fibromyalgia or other joint inflammatory disease including but not limited to gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease;
- Known or suspected positive serology for human immunodeficiency, hepatitis B or C virus;
- Patient has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product;
- Patient has history of substance abuse, drug addiction or alcoholism;
- Patient who have had participated in prior phase I/II clinical trial.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites
Cathay General Hospital
Taipei
Cheng Hsin General Hospital
Taipei
Far Eastern Memorial Hospital
Taipei
Mackay Memorial Hospital Institutional
Taipei
National Taiwan University Hospital
Taipei
Taipei City Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with DMARDs versus DMARDs Alone in Patients with Rheumatoid Arthritis
Read the detailed description
The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination with DMARDs versus DMARDs alone in patients with rheumatoid arthritis.
This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in combination with DMARDs versus DMARDs alone in patients with rheumatoid arthritis.
The study period for each patient will be 28 weeks, during which the patient will undergo screening for up to 14 days, followed by treatment of 24 weeks and follow-up period of 2 weeks. Each patient will be required to make a total of 9 visits.
- Conditions
- Combination With DMARDs
- Being tested
- DMARDs
- Keywords
- ENIA11, DMARDs, RA, TNF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMARDsDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | DMARDs alone Receives: Drug: DMARDs |
| ENIA11 | Experimental | ENIA11 25 mg Receives: Drug: DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 responder at last treatment visit
The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2017
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combination With DMARDsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mycenax Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsiao-Yi Lin, PHD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787149
- Sponsor's protocol ID
- TSHEN1201
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01787149
- Acronym / sponsor ID
- TSHEN1201
- Conditions
- Combination With DMARDs
- Keywords
- ENIA11, DMARDs, RA, TNF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Mycenax Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with DMARDs versus DMARDs Alone in Patients with Rheumatoid Arthritis
Detailed description
The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination with DMARDs versus DMARDs alone in patients with rheumatoid arthritis.
This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in combination with DMARDs versus DMARDs alone in patients with rheumatoid arthritis.
The study period for each patient will be 28 weeks, during which the patient will undergo screening for up to 14 days, followed by treatment of 24 weeks and follow-up period of 2 weeks. Each patient will be required to make a total of 9 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: DMARDsDMARDs alone |
| ENIA11 | Experimental | Drug: DMARDsENIA11 25 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients aged ≥ 20 years old;
- Patient meet ACR criteria for rheumatoid arthritis over 6 month duration;
- Patient with active disease at the time of screening as defined by six or more swollen joints and six or more tender joints;
- Presence of at least one of the following criteria:
- RA functional class I, II, or III;
Key exclusion criteria (17 listed)
- Active autoimmune disease (other than RA) requiring immunosuppressive therapy;
- In the opinion of the investigator, the patient shows persistent signs of immunosuppression;
- Known hypersensitivity to etanercept or ENIA11 or any of its components;
- Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a soluble TNF receptor (e.g., infliximab);
- Suspected or diagnosed pulmonary tuberculosis, or other chronic or current infectious disease at discretion of investigator;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMARDs | Drug | ENIA11, Placebo |
Primary outcome
ACR20 responder at last treatment visit
Time frame: Week 24
The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Related trials for Combination With DMARDs
Not yet recruitingPhase 4
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Rheumatoid Arthritis (RA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Yi Lin, PHD principal investigator
Taipei Veterans General Hospital, Taiwan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DMARDs in people with Combination With DMARDs, run by Mycenax Biotech Inc. at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR20 responder at last treatment visit (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.